MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 2; LIFT, PATIENT, NON-AC-POWERED

Model Number MS110-00-00

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Strangulation (2084); Insufficient Information (4580)

Event Date 12/27/2023

Event Type  Death  

Event Description

Following information reported by the customer, the patient was found with remote cord of the maxi sky 2 ceiling lift around his neck.The patient allegedly committed self-harm resulting in death.No malfunction of the device was reported by the customer.The customer is conducting their own investigation.

Manufacturer Narrative

The process of gathering information is ongoing.

Manufacturer Narrative

The customer internal investigation is ongoing, waiting for any further information regarding the event.

Manufacturer Narrative

The process of analyzing all gathered information is in progress.The results will be provided to the follow-up report.

Manufacturer Narrative

The customer is conducting their own investigation.No details regarding the cause of the patient's death were disclosed, however none arjo device malfunction was found that could have let to the patient's death.The instructions for use dedicated to maxi sky 2 (001-15698-en rev.4) warns in the important safety instructions section: "arjohuntleigh warns of possible strangulation risks related to the lifting strap, the hand control cable, the accessories' cable, or the emergency pull cord, and advises to take necessary precautions to prevent these." to sum up, it can be concluded that despite the arjo device being used in the event, it was not the direct cause of death.The patient allegedly committed self-harm.The reported event is a singular occurrence.The complaint was decided to be reportable due to allegation suggesting that the remote cord of the maxi sky 2 ceiling lift may have contributed to the patient's self-harm and subsequent death.

• Brand Name: MAXI SKY 2
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 18569258
• MDR Text Key: 333545662
• Report Number: 9681684-2024-00004
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MS110-00-00
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Date Device Manufactured: 05/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male